This invention relates generally to medical devices, and more particularly to devices and methods of use for removing a catheter, e.g., an introducer sheath, or other elongated tubular member which has been used to place a cardiac pacemaker (pacing) lead or other elongated intravascular instrument at a desired position within the body of a patient and without disturbing that pacing lead or instrument.
In current electrophysiology practice, the physician typically uses both hands to grasp and peel or split an introducer sheath to remove it from a cardiac pacing lead that has been positioned through the sheath to a desired location within the patient's body. A second person is sometimes used to hold the pacing lead in the desired position while the sheath is removed to ensure that the pacing lead is not displaced or moved. Alternatively, and more commonly, the physician holds the pacing lead with one hand, and withdraws the introducer sheath a short distance with the other hand. Then the physician grasps each half of the split peel-away hub and peels the sheath apart a short distance further. Once this is accomplished the physician again holds the pacing lead a little further up, and withdraws the introducer sheath a short distance further. This incremental series of motions is repeated several times until the introducer sheath is completely removed from the patient and the pacing lead, to minimize any displacement of the pacing lead.
A primary concern of the physician during this repetitive procedure centers around the numerous manipulations necessary to remove the introducer from the pacing lead, and the significant potential for moving the freshly placed tip of the pacing lead, since some pacing leads exhibit a tendency to move out of position if the lead is pulled or otherwise disturbed.
In U.S. Pat. No. 6,497,681 (Brenner), which is assigned to the same assignee as this invention there is disclosed a holding device for use with an elongated flexible member, e.g., a cardiac pacing lead, and a tubular introducer member, e.g., a peelable or tearable introducer sheath or catheter. The tubular introducer member is arranged to be extended into the body of a living being, with the elongated flexible member arranged to extend through the tubular introducer member into the being's body for location at a desired position. The tubular introducer member is arranged to be withdrawn proximally from the being's body after the elongated flexible member is in the desired position. The elongated flexible member has a proximal portion that deters the tubular introducer member from being withdrawn out of the being's body while the elongated flexible member is in place extending through the tubular introducer member. The holding device basically comprises a first portion, e.g., a “gripper” portion, and a second portion, e.g., a “splitter” portion. The first portion includes at least one contoured engagement surface or jaw to grasp a portion of the periphery of the elongated flexible member to hold the elongated flexible member at the desired position within the being's body. The second portion is arranged to cause the tubular introducer member to separate longitudinally. In particular, the second portion includes a sharp edge portion for engaging the tubular introducer member to split the tubular introducer member longitudinally, when the tubular introducer member is withdrawn, e.g., pulled proximally with respect to the holding device, as the holding device is held in place gripping the elongated flexible member. Once it is separated, e.g., split, longitudinally, the tubular introducer member can be removed from the elongated flexible member leaving the elongated flexible member at the desired position within the being's body.
Other U.S. patents relating to devices/methods for splitting catheters or sheaths are: U.S. Pat. No. 4,687,469 (Osypka), U.S. Pat. No. 4,997,424 (Little), U.S. Pat. No. 5,188,606 (Maloney et al.), U.S. Pat. No. 5,322,513 (Walker), U.S. Pat. No. 5,330,460 (Moss et al.), U.S. Pat. No. 5,687,727 (Kraus et al.), U.S. Pat. No. 5,713,867 (Morris), U.S. Pat. No. 5,951,518 (Licata et al.), U.S. Pat. No. 6,159,198 (Gardeski et al.), U.S. Pat. No. 6,280,433 (McIvor et al.), and U.S. Pat. No. 6,379,346 (McIvor, et al.).
While the aforementioned prior art devices may be suitable for their intended purposes they nevertheless leave something to be desired from one or more of the standpoints of simplicity of construction, ease of use and effectiveness.